OXYCODONE HYDROCHLORIDE solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

थमां उपलब्ध:

RedPharm Drug, Inc.

INN (इंटरनेशनल नाम):

OXYCODONE HYDROCHLORIDE

रचना:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Oxycodone Hydrochloride Oral Solution, USP is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate. Oxycodone Hydrochloride Oral Solution, USP is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. any patient who has or is suspected of having paralytic ileus. patients with acute or severe bronchial asthma or hypercarbia. patients with known hypersensitivity to oxycodone, oxycodone salts, or any component of this product 8.1 Pregnancy Pregnancy Category B: There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. Because animal reproduction studies are not always predictive of human response, oxycodone should be used during pregnancy only if clearly needed. Teratoge

उत्पाद समीक्षा:

16.1 How Supplied Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL is available as follows: NDC 60432-706-05: 500 mL plastic bottle packaged with calibrated measuring cup 16.2 Storage and Handling All opioids, including Oxycodone Hydrochloride Oral Solution, USP, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly. Dispense in a tight, light-resistant container as defined in the USP/NF. Keep in secured area and protect from diversion. Store at controlled room temperature 20°-25°C (68°- 77°F).

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride solution
RedPharm Drug, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Oxycodone Hydrochloride (ox-ee-CO-dohn) (CII)Oral Solution, USP
IMPORTANT: Keep Oxycodone Hydrochloride Oral Solution, USP in a safe
place away from children.
Accidental use by a child is a medical emergency and
can cause death. If a child accidentally takes Oxycodone Hydrochloride
Oral Solution, USP, get emergency
help right away.
Read the Medication Guide that comes with Oxycodone Hydrochloride Oral
Solution, USP before you start
taking it and each time you get a new prescription. There may be new
information. This Medication Guide
does not take the place of talking to your healthcare provider about
your medical condition or your treatment.
What Is The Most Important Information I Should Know About Oxycodone
Hydrochloride Oral Solution?
Oxycodone Hydrochloride Oral Solution can cause serious side effects,
including death.
Take Oxycodone Hydrochloride Oral Solution exactly as prescribed by
your healthcare provider. If you take
the wrong dose or strength of Oxycodone Hydrochloride Oral Solution,
you could overdose and die.
It is especially important when you take Oxycodone Hydrochloride Oral
Solution that you know exactly what
dose and strength to take, and the right way to measure your medicine.
Your healthcare provider or
pharmacist should show you the right way to measure your medicine.
Always use the dosing cup provided
with Oxycodone Hydrochloride Oral Solution to help make sure you
measure the right amount.
Do not drink alcohol. Using alcohol with Oxycodone Hydrochloride Oral
Solution may increase your risk of
dangerous side effects, including death.
What is Oxycodone Hydrochloride Oral Solution?
Oxycodone Hydrochloride Oral Solution is in a group of drugs called
narcotic pain medicine. Oxycodone
Hydrochloride Oral Solution is only for adults who have moderate to
severe pain.
A prescription medicine that is used to manage moderate to severe pain
that is expected to last a short period
o

उत्पाद विशेषताएं

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
REDPHARM DRUG, INC.
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BOXED WARNING
Take care when prescribing and administering Oxycodone Hydrochloride
Oral
Solution, USP 5 mg per 5 mL to avoid dosing errors due to confusion
between mg
and mL, and other oxycodone ...
WARNING: RISK OF MEDICATION ERRORS
Take care when prescribing and administering Oxycodone Hydrochloride
Oral
Solution, USP 5 mg per 5 mL to avoid dosing errors due to confusion
between mg
and mL, and other oxycodone solutions with different concentrations,
which could
result in accidental overdose and death.
Take care to ensure the proper dose is communicated and dispensed.
Keep Oxycodone Hydrochloride Oral Solution, USP out of the reach of
children. In
case of accidental ingestion, seek emergency medical help immediately.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Oxycodone
Hydrochloride Oral Solution, USP safely and effectively. See full
prescribing information
for Oxycodone Hydrochloride Oral Solution, USP.
Oxycodone Hydrochloride Oral Solution, USP CII
Initial U.S. Approval: 1950
WARNING: RISK OF MEDICATION ERRORS
TAKE CARE WHEN PRESCRIBING AND ADMINISTERING OXYCODONE HYDROCHLORIDE
ORAL SOLUTION, USP 5 MG PER 5 ML TO AVOID DOSING ERRORS DUE TO
CONFUSION
BETWEEN MG AND ML, AND OTHER OXYCODONE SOLUTIONS WITH DIFFERENT
CONCENTRATIONS, WHICH COULD RESULT IN ACCIDENTAL OVERDOSE AND DEATH.
Take care to ensure the proper dose is communicated and dispensed.
Keep Oxycodone Hydrochloride Oral Solution, USP out of the reach of
children. In case
of accidental ingestion, seek emergency medical help immediately.
INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution, USP is an opioid agonist
indicated for the
management of moderate to severe pain where the use of an opioid
analgesic is
appropriate. (1)
DOSAGE AND ADMINISTRATION
Dosage should be individualized based on the severity of pain, and
patient response.
(2.1)
Patients who have not been receiving opioid analgesics shou